Cataract Surgery With Intracameral Triamcinolone in Infants

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Drug: Triamcinolone acetonide; Drug: Prednisolone syrup

• Registration Number: NCT01800708
• Lead Sponsor: Fundação Altino Ventura

Brief Summary

The aim of the present study is to investigate the outcomes of congenital cataract surgery when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral prednisolone.

This is a prospective, randomized clinical trial. Sixty children will be submitted to congenital cataract surgery younger than 2 years of age. They will be randomly divided in two groups. The study group will receive an intraoperative intracameral triamcinolone acetonide injection. The control group will receive prednisolone syrup postoperatively. The surgical outcomes will be assessed after one year.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Primary Completion: 2013-03
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-13
• Last Update Posted: 2013-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients younger than 2 years of age
• Unilateral or bilateral congenital cataracts compromising the red reflex

Exclusion Criteria

• Corneal opacity
• Glaucoma
• Aniridia
• Subluxated cataract
• Traumatic cataract
• Complex microphthalmia
• Persistant hyperplastic primary vitreous
• Retinal detachment
• Patients with intraoperative complications, such as IOL implanted in the sulcus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Triamcinolone acetonide	Triamcinolone acetonide	The study group will receive an intraoperative intracameral injection of triamcinolone acetonide
Prednisolone syrup	Prednisolone syrup	The control group will receive prednisolone syrup postoperatively

Primary Outcome Measures

Name	Time	Method
Visual axis obscuration	1 year after surgery	Visual axis obscuration will be evaluated under sedation, with a dilated pupil. All patients will be classified by the principal investigator as having or not a significant visual axis obscuration, based on the red reflex.
Intraocular pressure	1 year after surgery

Trial Locations

Locations (1)

Altino Ventura Foundation; 🇧🇷 Recife, Pernambuco, Brazil